Cohort Study of the Clinical Course of Macular Diseases in Kagawa
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|ClinicalTrials.gov Identifier: NCT02321267|
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : March 7, 2018
Macular diseases often cases severe visual impairment. Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of various macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth. The advance in vitrectomy improve visual outcomes in some maculae diseases, including epiretinal membrane (ERM), macular hole (MH), vitreomacular traction syndrome (VMTS).
Patients with such macular diseases are registered and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.
|Condition or disease||Intervention/treatment||Phase|
|Macular Disease||Drug: ranibizumab, aflibercept, pegaptanib, verteporphin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cohort Study of the Clinical Course of Macular Diseases in Kagawa (Kagawa Macula Cohort Study)|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
Macular disease with adequate treatments
Macular diseases can be treated with most appropriate treatment, including pegaptanib, ranibizumab, afibercept, visudyne, or vitrectomy.
Drug: ranibizumab, aflibercept, pegaptanib, verteporphin
ranibizumab, intravitreal injections, 0.5mg, monthly or less aflibercept,intravitreal injections, 2.0mg, monthly or less pegaptanib, intravitreal injections, 0.3mg, every 6-week pars plana vitrectomy, once verteporphin, iv, 6mg/㎡
Other Name: Lucentis, Eylea, Macugen, Vizudyne
- Change of best-collected visual acuity from baseline at 5 years [ Time Frame: Five years after the registration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321267
|Contact: Chika Akutaemail@example.com|
|Kagawa University Faculty of Medicine||Recruiting|
|Miki, Kagawa, Japan, 761-0793|
|Contact +81878912211 firstname.lastname@example.org|
|Principal Investigator:||Akiataka Tsujikawa, MD||Kagawa Univerisity Faculty of Medicine|